MAUDE Adverse Event Report: KANEKA CORPORATION R2P METACROSS RX R2P METACROSS RX PTA BALLOON DILATATION CATHETER

Model Number BD-P50040ER

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Please find below the results of our investigation. The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections for every product, and the finished product inspections on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. We will submit a follow-up report as soon as the actual device testing is completed.

Event Description

Left radial access, 6fr 10cm slender, used gwa track 018, pre-dilated focal proximal sfa lesion (90%) with crosstella 2x40x200, then used angiosculpt 5x20x137,then exchanged for gwa 35 260cm, successfully delivered a misago 6x40x200, attempted to post dilate with abbott vascular armada 5x40x135 (not successful, would advance into 1/3 of the stent but no further), attempted to post dilate with r2p metacross 5x40x200 and noticed that while in the descending aorta, the balloon stopped advancing. Physician stopped and went to look. Catheter was visibly looped and the physician tried to advance and pull back to unloop the catheter. Unsuccessful. He then tried to remove the system (wire, balloon and sheath) but the balloon system started causing patient discomfort and resistance was observed. Everything was left in and the patient was transported by ambulance to the university of iowa for vascular surgery intervention. A radial cutdown was performed below the elbow and the system was removed in sections by using a wire cutter. The balloon system was intact but the catheter had kinked and was not able to straighten to remove. The patient received one unit of blood and a xenosure biologic patch to repair the radial artery. Good radial and ulnar pulses were observed at the end of the procedure.

• Brand Name: R2P METACROSS RX
• Type of Device: R2P METACROSS RX PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 53082 88; JA 5308288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32 akasaka; minato-ku; tokyo 10760-28 ; JA 1076028
• MDR Report Key: 12244571
• MDR Text Key: 264050943
• Report Number: 3002808904-2021-00007
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: BD-P50040ER
• Device Catalogue Number: BD-P50040ER
• Device Lot Number: SR030460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/29/2021 Patient Sequence Number: 1